The PBRER provides a comprehensive and critical analysis of the overall benefit-risk balance of a medicinal product, updated periodically post-authorisation. Unlike PSURs, they must address not only the safety but also the efficacy and effectiveness of the product, which helps to evaluate whether the therapeutic benefits of the product continue to outweigh the risks. The medical writer’s role is essential when planning and managing the submission, ensuring consistency across different sections but also with other pharmacovigilance documents.